regulatory
confidence high
sentiment positive
materiality 0.65
CMS expands carotid stenting coverage to asymptomatic/standard-risk patients; InspireMD supports
InspireMD, Inc.
- CMS final NCD extends CAS coverage to asymptomatic and standard-risk patients, expanding addressable market.
- InspireMD advancing CAS and TCAR programs in U.S. and E.U. using CGuard EPS stent system.
- C-GUARDIANS IDE trial completed enrollment; 30-day safety results at VIVA Nov 1, 2023; PMA filing anticipated H2 2024.
- CGuard EPS stent studied in nine clinical trials with >1,850 patients and over 40,000 real-world procedures.
- CEO says CMS decision will accelerate shift from open surgery to endovascular 'stent first' approach.